Metastatic colorectal cancer: irinotecan plus infusional, bolus or oral fluoropyrimidines as first-line treatment
David J Kerr
Correspondence Department of Clinical Pharmacology, University of Oxford, Old Road Campus Research Building, Old Road Campus off Roosevelt Drive, Headington, Oxford OX3 7DQ, UK
Email david.kerr@clinicalpharmacology.oxford.ac.uk
This article has no abstract so we have provided the first paragraph of the full text.
This complex factorial trial set out to accomplish two broad objectives, firstly to compare three chemotherapy regimens combining different fluoropyrimidine agents with irinotecan and, secondly, to determine whether addition of the cyclo-oxygenase 2 inhibitor, celecoxib, increased the efficacy of chemotherapy. This study was initially powered to recruit 900 patients; however, the design was altered by two events that the authors could not have anticipated, namely, approval of bevacizumab by the FDA in April 2004, and worldwide withdrawal of rofecoxib by Merck at a similar time owing to concerns over cardiovascular safety. The approval of bevacizumab led to a major trial amendment to incorporate this agent into the chemotherapy combination regimens and closure of enrollment to the trial after randomization of 547 patients, owing to recruitment fall-off.
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